BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1822561 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01651
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS, CONCLUSION: HISTORY OF TRANSIENT ISCHEMIC ATTACK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN 8.7 CM SACCULAR ABDOMINAL AORTIC ANEURYSM 11 MONTHS AGO. THE AORTIC NECK HAS AN INFRARENAL ANGULATION OF 40 DEGREES. THE AORTIC NECK WAS 23 MM IN DIAMETER AND 40 MM LONG. THE ILIAC ARTERIES WERE MODERATELY TORTUOUS. IT WAS REPORTED THERE WERE NO ISSUES DURING THE IMPLANTATION OF THE STENT GRAFT. IT WAS REPORTED THAT ONE MONTH AGO, THE PT HAD A CVA. THE RELATION TO THE DEVICE AND TO THE PROCEDURE WAS NOT REPORTED. THE PT WAS HOSPITALIZED; DETAILS OF TREATMENT NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00354846

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR